Tavapadon is probably the primary new Parkinson’s illness drug in 50 years. Credit score: John DiJulio, College Communications
The U.S. Meals and Drug Administration is reviewing a brand new Parkinson’s illness drug referred to as tavapadon that might give individuals with the illness extra management over their actions.
If accepted, it will be the primary main new drug remedy for Parkinson’s in half a century. Richard Mailman, a College of Virginia professor of pharmacology and neuroscience, has spent many years attempting to deliver this class of drug to sufferers.
Because the FDA deliberates and forward of a UVA Parkinson’s fundraiser, Mailman spoke with UVA Immediately about tavapadon and the way it may change the lives of individuals dwelling with Parkinson’s.
How did you come to develop Parkinson’s remedies?
I acquired a doctorate in physiology a few years in the past and, within the strategy of doing my thesis work, I turned very desirous about a category of molecules that I had used as probes to have a look at features within the liver. I noticed they have been candidates to deal with central nervous system issues and began studying about central nervous system issues, which excited me sufficient to reorient my profession.
Just a few years later, I ended up as an assistant professor finding out the mind. My first concept was to find new methods to deal with schizophrenia, which at the moment was handled with a category of medication that have been efficient, however had loads of negative effects. By the point I really acquired my first NIH grant, I noticed all of my early predictions have been fallacious, and as a substitute I had this new concept of how you can deal with Parkinson’s illness.
What discoveries helped information your analysis towards growing tavapadon?
There was a gaggle at Johns Hopkins College that teased aside the neurocircuitry of an space of the mind referred to as the basal ganglia, which is the place the D1 dopamine receptor (our drug goal) is expressed probably the most. On the similar time, a gaggle on the College of Virginia found that the D1 receptor was situated in a single essential group of cells within the basal ganglia that we thought have been necessary.
Since 1969, the gold commonplace drug has been levodopa, which makes extra dopamine within the mind. The issue was there was no selective drug to activate the D1 receptor. So, we pulled collectively a staff of scientists, and inside 10 years we found the primary drug of this sort and examined it in cells, totally different species of animals, and really in man. The drug labored however it was solely injectable and lasted just for a number of hours making it impractical for on a regular basis use.
We spent years attempting to curiosity pharmaceutical corporations within the problem of creating a drug of this mechanism that might be given as a tablet. Lastly, in 2007, a gathering with Pfizer scientists acquired them excited, and over the following 4 years they did some good medicinal chemistry to find and do preliminary testing of a D1 agonist that might be given as a tablet.
What’s the course of for having a drug thought of by the FDA?
The method of getting an important concept is known as drug discovery. Then begins the lengthy and costly effort referred to as medical growth, which begins by exhibiting that the compound you’ve got found, your drug candidate, is protected. That is adopted by sequential medical trials divided into phases, every of which makes use of increasingly analysis topics.
If the ends in the final of those, Part 3, are optimistic, corporations will compile all the knowledge and submit a New Drug Software (NDA) to regulatory businesses just like the FDA for overview. Two weeks in the past, AbbVie Inc. submitted an NDA for a drug referred to as tavapadon, which might be the primary oral D1 agonist ever utilized in man. The FDA takes anyplace between six months and two years to overview the NDA and both give approval or not. I believe this NDA will get accepted slightly faster than common, so we’re guessing that it could be earlier than the top of 2026.
What are you able to inform me concerning the present remedy, Levodopa?
Levodopa is made in our brains naturally because the fast biochemical precursor of dopamine. It is made in dopamine nerve cells after which transformed into dopamine, which the nerve cells can then launch to activate different cells, rising the quantity of dopamine the nerve cells make and launch.
The issue in Parkinson’s illness is that you just lose a selected group of dopamine nerve cells, often 50%–60% of them by the point a affected person has their first signs. Till then, your mind compensates properly for the loss, however when you get to that threshold, you begin getting tremors, slowness of motion, and different starting signs.
Levodopa offers spectacular symptom aid for 5 years or extra, which physicians name “the honeymoon period.” Sadly, as dopamine nerve cells proceed to die, the more durable it’s for them to transform levodopa into dopamine. So, sufferers begin by taking levodopa 3 times a day, however after a few years, they need to take the medication at increased doses, typically as usually as each two hours. Tavapadon is taken as soon as per day, and there may be some proof it would work a lot better in later levels of Parkinson’s.
Though tavapadon is a significant advance, our analysis will proceed for brand spanking new medicine, in addition to exploring different medical indications like ADHD, autism and cognition the place the D1 receptor could play an necessary function. The imaginative and prescient of Manning Institute now beneath building within the UVA Fontaine Analysis Park was conceived to assist us and others at UVA make these higher medicines quicker.
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Q&A: New drug being reviewed by the FDA to deal with Parkinson’s illness (2025, October 29)
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